Med-Info. Introduction to Korean medical device regulations. TÜV SÜD Product Service GmbH

Transcription

1 Med-Info International expert information for the medical device industry Introduction to Korean medical device regulations The Ministry of Food and Drug Safety (MFDS) is the healthcare agency having overall responsibility for in Korea. Structure of Korean legislation Medical Devices Act (MDA) Enforcement Decree of MDA Enforcement Regulations of MDA framework of major regulatory programs and basis for GMP requirements in Annexes MFDS notifications of MDA most detailed regulations for technical requirements, review standards, and processes* MFDS standards and guidelines guidelines for industry and MFDS assessors MFDS notifications related to Under the legislations, most detailed regulations for technical requirements, review standards, and processes are regulated as MFDS notifications. Some important notifications for device registration process are: Regulation on approval, notification, and assessment of Standards for manufacture and quality management of (GMP) Regulations for product classification of Re-evaluation (re-examination) of MFDS standards and guidelines related to MFDS standards are published upon demands from the industry and assessors, referring to widely recognized international standards, e.g. IEC and ISO standards, but considering national deviations. The standards are: Horizontal standards for electrical safety, biological safety, electro-compatibility and safety testing requirements Vertical standards for respective product categories Guidelines as nonbinding documents are published for industry and MFDS assessors. Examples are: Guideline on medical device evaluation Guidelines on technical document review Guideline on labeling for Guideline on GMP audit Guideline on GMP audit for foreign manufacturers of imported products * The regulations with most current versions are to be checked via the MFDS website ( The laws and notifications are partly available in English, but not always as latest versions. TÜV SÜD Product Service GmbH

2 Classification of (MD) and responsible organizations Class* Criteria Product assessment** Product approval GMP audit TDR SER IV high risk III II I medium serious potential risk low potential risk little potential risk MFDS MFDS MFDS, Head Office Third-party TF MFDS MDITAC*** reviewer MDITAC*** Third-party GMP inspector + MFDS officer n/a * The classification of each medical device is listed in a MFDS notification. ** A technical document review is a general technical file review (TDR) for those products that are basically the same as an already approved product, whereas a safety and efficacy review (SER) is required for devices unlike those currently available on the market falling under new structure, new performance, new intended use, and newly developed. *** Medical Device Information & Technology Assistance Center Importer To access the Korean medical device market, the importer based in Korea is to be designated for foreign manufacturers, and has to be: a business license holder for medical device import, possibly a subsidiary of a foreign manufacturer, an independent distributor, local manufacturer or other legal entity, an applicant for product registration process and responsible for postmarket surveillance. Premarket requirements For marketing, the following requirements are to be fulfilled: Product license Quality system regulation KGMP audit and approval Product license All require a premarket registration from MFDS before importing and putting on the market. There are two types of premarket product licenses: Premarket notification for Class I devices Premarket approval for Class II, III and IV devices

3 Premarket registration Class I Class II, III, IV Notification Approval product notification general technical document review safety and efficacy review Technical documents Technical documents Test reports Test reports Clinical study reports Premarket notification for Class I devices Premarket notification requires only a documentary review of product information. Manufactures or importers Auto-registration by the online submission A certificate of notification will be available online MFDS systems (an electronical window for civil petitions to MFDS) MFDS does not accept: Submission for a medical device requiring the approval process Submission for a nonmedical device Premarket approval for Class II, III and IV devices For Class II the application must be submitted to MDITAC for product approval, after complete technical document review by third-party reviewers. TÜV SÜD Korea is a third-party reviewer organization for technical document review for all product categories of Class II. For Class III and IV the application has to be submitted to MFDS, Head Office, for product approval after technical document review by MFDS.

4 review of technical documents Notification of conformity from technical document review certificate of product approval Certificate of product approval In case of Class III and IV devices the applications for technical document review and for product approval can be submitted together. The application for certificate of product approval is a formal process by MFDS without any further technical review. Technical document review A technical document review is a general technical document review (TDR) for those products that are basically the same as an already approved product, whereas a safety and efficacy review (SER) is required for devices unlike those currently available on the market falling under new structure, new performance, new intended use, and newly developed. Technical documents for all Class II are reviewed by third parties, whereas Class III and IV are reviewed by MFDS. General technical document review (TDR) Devices substantially equivalent as previously approved products Clinical study reports are not required Safety and efficacy review (SER) Required for devices with new-to-market features new developments, new performance, new structure, and/or new intended use Significant difference affecting safety and effectiveness Clinical study reports are essential, in addition to TDR requirements Technical document file contains Intended use (IFU) Physical, chemical characteristics Biological safety Electromagnetic compatibility Stability report (including shelf-life test) Principle of operation Electrical, mechanical safety Irradiation safety Function In addition to TDR, SER requires: Original developer Clinical investigation data Design history and background Market history in foreign countries In the product registration procedure, the Class II medical devices defined as equivalency-notified products are exempt from the technical document review process, and those defined as modified products are partially exempt. What is a equivalency-notified product? Medical devices, which are equivalent to premarketed devices for the intended use, operation principle or used materials (for nonactive ), performance, test specification and operation method, etc. Additional information has to be given for the device under review Equivalency-notified and regularly updated by MFDS Test report required to identify the equivalency issued by MFDS-registered test laboratories Medical device testing The test reports issued by the following laboratories are recognized to support the function, safety and effectiveness MFDS-registered laboratories IEC-registered laboratories (CBTL) KOLAS-accredited laboratories (Korea Laboratory Accreditation Scheme acc. to ISO 17025) GLP laboratories accredited according to OECD rules TÜV SÜD can provide IEC reports and GLP reports for MFDS registration. Clinical trials Required for SER products MFDS approval required for protocol and clinical trial studies Clinical investigation by medical device clinical trial centers qualified by MFDS (GCP)

5 The clinical studies performed in foreign countries are recognized only if: Compliance to GCP and ISO The study reports have been accepted by the healthcompetent authority of OECD member countries in the product registration process. Quality system regulations (KGMP) All are required to be manufactured under GMP. Premarket GMP audit is mandatory for all Class II, III and IV devices and Class I (sterile and measuring devices). Certification of compliance to Standards for manufacturing and quality management of medical devices (KGMP, similar to ISO 13485) Both, document review and site inspection conducted by third-party GMP inspector organization, the audit team accompanied by MFDS officer Update every 3 years Currently, a MFDS guideline was published on GMP audit for foreign manufacturers of imported products and implemented with the time frame: Class IV: from April 8, 2012 Class III: from 2013 Class II from 2014 In case of many manufacturing sites per importer, the manufacturing sites will be sampled depending on the criteria of product risk, importing volume, PMS data, etc. The following issues are not focused during TDR/SER processes but during the GMP audit: Sterilization process validation Risk management file Postmarket surveillance The product license holder (local manufacturer and importer) has legal responsibility for the product marketing process and postmarket surveillance activities: Patient record control required for designated products for medical device tracking such as cardiac implant devices, breast implants, implantable infusion devices, defibrillator and continuous ventilator Adverse event/safety alert reporting for adverse effect, new safety information from PMCF and/or literature Recalls in case of effects on safety, effectiveness or quality defects Re-evaluation and re-examination Our service for medical device registration Technical document review service for all Class II as third-party reviewer, registered to MFDS CB report issuance for electrical/electronic GLP report issuance for biocompatibility of body-contact Pretechnical meeting to identify the gaps for MFDS approval KGMP mock inspection service Your contact partner at TÜV SÜD Product Service can provide further information. Foreign Affairs Phone: MHS-FA@tuev-sued.de TÜV SÜD Korea Phone: mhs_enquiry@tuv-sud.kr TÜV SÜD Product Service GmbH, Medical and Health Services, Ridlerstr. 65, Munich TÜV SÜD Korea Ltd. 29F, Two IFC, 10, Gukjegeumyung-ro, Yeongdeungpo-gu, Seoul, 07326, Republic of Korea (South Korea) TÜV SÜD Product Service GmbH I PS-MKG/MHS/medinfo/10.2/en/DE